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Details for New Drug Application (NDA): 020753
NDA 020753 describes AROMASIN, which is a drug marketed by Pharmacia And Upjohn and is included in one NDA. It is available from two suppliers. Additional details are available on the AROMASIN profile page.
The generic ingredient in AROMASIN is exemestane. There are fifteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the exemestane profile page.
The generic ingredient in AROMASIN is exemestane. There are fifteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the exemestane profile page.
Summary for 020753
| Tradename: | AROMASIN |
| Applicant: | Pharmacia And Upjohn |
| Ingredient: | exemestane |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 020753
| Mechanism of Action | Aromatase Inhibitors |
Suppliers and Packaging for NDA: 020753
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AROMASIN | exemestane | TABLET;ORAL | 020753 | NDA | Pharmacia and Upjohn Company LLC | 0009-7663 | 0009-7663-04 | 30 TABLET in 1 BOTTLE (0009-7663-04) |
| AROMASIN | exemestane | TABLET;ORAL | 020753 | NDA AUTHORIZED GENERIC | Greenstone LLC | 59762-2858 | 59762-2858-1 | 30 TABLET, SUGAR COATED in 1 BOTTLE (59762-2858-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Oct 21, 1999 | TE: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 020753
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Pharmacia And Upjohn | AROMASIN | exemestane | TABLET;ORAL | 020753-001 | Oct 21, 1999 | Start Trial | Start Trial |
| Pharmacia And Upjohn | AROMASIN | exemestane | TABLET;ORAL | 020753-001 | Oct 21, 1999 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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